List of Excipients in API dapagliflozin
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Excipients in NDA-approved (novel) drugs containing dapagliflozin
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | FARXIGA | dapagliflozin | 0310-6205 | ANHYDROUS LACTOSE | |
| AstraZeneca Pharmaceuticals LP | FARXIGA | dapagliflozin | 0310-6205 | CELLULOSE, MICROCRYSTALLINE | |
| AstraZeneca Pharmaceuticals LP | FARXIGA | dapagliflozin | 0310-6205 | CROSPOVIDONE | |
| AstraZeneca Pharmaceuticals LP | FARXIGA | dapagliflozin | 0310-6205 | MAGNESIUM STEARATE | |
| AstraZeneca Pharmaceuticals LP | FARXIGA | dapagliflozin | 0310-6205 | SILICON DIOXIDE | |
| A-S Medication Solutions | FARXIGA | dapagliflozin | 50090-3481 | ANHYDROUS LACTOSE | |
| A-S Medication Solutions | FARXIGA | dapagliflozin | 50090-3481 | CELLULOSE, MICROCRYSTALLINE | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing dapagliflozin
Detailed excipient profiles for dapagliflozin
Excipient focus: ANHYDROUS LACTOSE
dapagliflozin drug variants containing ANHYDROUS LACTOSE
dapagliflozin drug variants not containing ANHYDROUS LACTOSE
Excipient focus: CARBOXYMETHYLCELLULOSE SODIUM
dapagliflozin drug variants containing CARBOXYMETHYLCELLULOSE SODIUM
dapagliflozin drug variants not containing CARBOXYMETHYLCELLULOSE SODIUM
Excipient focus: CELLULOSE, MICROCRYSTALLINE
dapagliflozin drug variants containing CELLULOSE, MICROCRYSTALLINE
dapagliflozin drug variants not containing CELLULOSE, MICROCRYSTALLINE
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dapagliflozin | 59651-159 |
| Sun Pharmaceutical Industries Inc | dapagliflozin and metformin hydrochloride | 63304-026 |
| >Company | >Ingredient | >NDC |
Excipient focus: COPOVIDONE
dapagliflozin drug variants containing COPOVIDONE
| Company | Ingredient | NDC |
|---|---|---|
| Cipla USA Inc | dapagliflozin | 69097-388 |
| Ascend Laboratories LLC | dapagliflozin and metformin hydrochloride | 67877-619 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing COPOVIDONE
Excipient focus: CROSCARMELLOSE SODIUM
dapagliflozin drug variants containing CROSCARMELLOSE SODIUM
dapagliflozin drug variants not containing CROSCARMELLOSE SODIUM
Excipient focus: CROSPOVIDONE
dapagliflozin drug variants containing CROSPOVIDONE
dapagliflozin drug variants not containing CROSPOVIDONE
Excipient focus: FD&C YELLOW NO. 6
dapagliflozin drug variants containing FD&C YELLOW NO. 6
| Company | Ingredient | NDC |
|---|---|---|
| Macleods Pharmaceuticals Limited | dapagliflozin and metformin hydrochloride | 33342-406 |
| Ascend Laboratories LLC | dapagliflozin and metformin hydrochloride | 67877-619 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing FD&C YELLOW NO. 6
Excipient focus: FD&C YELLOW NO. 6 ALUMINUM LAKE
dapagliflozin drug variants containing FD&C YELLOW NO. 6 ALUMINUM LAKE
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dapagliflozin and metformin hydrochloride | 59651-154 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing FD&C YELLOW NO. 6 ALUMINUM LAKE
Excipient focus: FERRIC OXIDE RED
dapagliflozin drug variants containing FERRIC OXIDE RED
dapagliflozin drug variants not containing FERRIC OXIDE RED
Excipient focus: FERRIC OXIDE YELLOW
dapagliflozin drug variants containing FERRIC OXIDE YELLOW
dapagliflozin drug variants not containing FERRIC OXIDE YELLOW
Excipient focus: FERROSOFERRIC OXIDE
dapagliflozin drug variants containing FERROSOFERRIC OXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Novadoz Pharmaceuticals LLC | dapagliflozin and metformin hydrochloride | 72205-434 |
| AstraZeneca Pharmaceuticals LP | dapagliflozin saxagliptin and metformin hydrochloride | 0310-6925 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing FERROSOFERRIC OXIDE
Excipient focus: FERROUS OXIDE
dapagliflozin drug variants containing FERROUS OXIDE
| Company | Ingredient | NDC |
|---|---|---|
| AstraZeneca Pharmaceuticals LP | dapagliflozin and saxagliptin | 0310-6780 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing FERROUS OXIDE
Excipient focus: GLYCERYL MONO- AND DICAPRYLOCAPRATE
dapagliflozin drug variants containing GLYCERYL MONO- AND DICAPRYLOCAPRATE
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dapagliflozin and metformin hydrochloride | 59651-154 |
| Aurobindo Pharma Limited | dapagliflozin | 59651-159 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing GLYCERYL MONO- AND DICAPRYLOCAPRATE
Excipient focus: GLYCERYL MONOCAPRYLOCAPRATE
dapagliflozin drug variants containing GLYCERYL MONOCAPRYLOCAPRATE
| Company | Ingredient | NDC |
|---|---|---|
| Ascend Laboratories LLC | dapagliflozin and metformin hydrochloride | 67877-619 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing GLYCERYL MONOCAPRYLOCAPRATE
Excipient focus: HYDROCHLORIC ACID
dapagliflozin drug variants containing HYDROCHLORIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| AstraZeneca Pharmaceuticals LP | dapagliflozin saxagliptin and metformin hydrochloride | 0310-6925 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing HYDROCHLORIC ACID
Excipient focus: HYDROXYETHYL CELLULOSE
dapagliflozin drug variants containing HYDROXYETHYL CELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| Ascend Laboratories LLC | dapagliflozin | 67877-608 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing HYDROXYETHYL CELLULOSE
Excipient focus: HYDROXYPROPYL CELLULOSE
dapagliflozin drug variants containing HYDROXYPROPYL CELLULOSE
dapagliflozin drug variants not containing HYDROXYPROPYL CELLULOSE
Excipient focus: HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
dapagliflozin drug variants containing HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
| Company | Ingredient | NDC |
|---|---|---|
| Florida Pharmaceutical Products LLC | dapagliflozin | 71921-420 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
Excipient focus: HYPROMELLOSE
dapagliflozin drug variants containing HYPROMELLOSE
| Company | Ingredient | NDC |
|---|---|---|
| Ajanta Pharma USA Inc | dapagliflozin | 27241-151 |
| Novadoz Pharmaceuticals LLC | dapagliflozin and metformin hydrochloride | 72205-434 |
| Novadoz Pharmaceuticals LLC | dapagliflozin and saxagliptin | 72205-438 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing HYPROMELLOSE
Excipient focus: HYPROMELLOSE 2208
dapagliflozin drug variants containing HYPROMELLOSE 2208
dapagliflozin drug variants not containing HYPROMELLOSE 2208
Excipient focus: HYPROMELLOSE 2910
dapagliflozin drug variants containing HYPROMELLOSE 2910
dapagliflozin drug variants not containing HYPROMELLOSE 2910
Excipient focus: HYPROMELLOSES
dapagliflozin drug variants containing HYPROMELLOSES
| Company | Ingredient | NDC |
|---|---|---|
| Macleods Pharmaceuticals Limited | dapagliflozin and metformin hydrochloride | 33342-406 |
| Lupin Pharmaceuticals Inc | dapagliflozin and metformin hydrochloride | 70748-101 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing HYPROMELLOSES
Excipient focus: ISOPROPYL ALCOHOL
dapagliflozin drug variants containing ISOPROPYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Cipla USA Inc | dapagliflozin | 69097-388 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing ISOPROPYL ALCOHOL
Excipient focus: LACTOSE
dapagliflozin drug variants containing LACTOSE
| Company | Ingredient | NDC |
|---|---|---|
| Ajanta Pharma USA Inc | dapagliflozin | 27241-151 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing LACTOSE
Excipient focus: LACTOSE MONOHYDRATE
dapagliflozin drug variants containing LACTOSE MONOHYDRATE
dapagliflozin drug variants not containing LACTOSE MONOHYDRATE
Excipient focus: LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE
dapagliflozin drug variants containing LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| Ascend Laboratories LLC | dapagliflozin and metformin hydrochloride | 67877-619 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE
Excipient focus: MAGNESIUM ALUMINOMETASILICATE TYPE I-B
dapagliflozin drug variants containing MAGNESIUM ALUMINOMETASILICATE TYPE I-B
| Company | Ingredient | NDC |
|---|---|---|
| Florida Pharmaceutical Products LLC | dapagliflozin | 71921-420 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing MAGNESIUM ALUMINOMETASILICATE TYPE I-B
Excipient focus: MAGNESIUM STEARATE
dapagliflozin drug variants containing MAGNESIUM STEARATE
dapagliflozin drug variants not containing MAGNESIUM STEARATE
Excipient focus: MANNITOL
dapagliflozin drug variants containing MANNITOL
dapagliflozin drug variants not containing MANNITOL
Excipient focus: MICROCRYSTALLINE CELLULOSE 101
dapagliflozin drug variants containing MICROCRYSTALLINE CELLULOSE 101
| Company | Ingredient | NDC |
|---|---|---|
| Sun Pharmaceutical Industries Inc | dapagliflozin and metformin hydrochloride | 63304-026 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing MICROCRYSTALLINE CELLULOSE 101
Excipient focus: MICROCRYSTALLINE CELLULOSE 112
dapagliflozin drug variants containing MICROCRYSTALLINE CELLULOSE 112
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dapagliflozin | 59651-159 |
| Sun Pharmaceutical Industries Inc | dapagliflozin and metformin hydrochloride | 63304-026 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing MICROCRYSTALLINE CELLULOSE 112
Excipient focus: POLOXAMER 407
dapagliflozin drug variants containing POLOXAMER 407
| Company | Ingredient | NDC |
|---|---|---|
| Zydus Pharmaceuticals USA Inc | dapagliflozin | 70710-1380 |
| Zydus Lifesciences Limited | dapagliflozin | 70771-1714 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POLOXAMER 407
Excipient focus: POLYETHYLENE GLYCOL
dapagliflozin drug variants containing POLYETHYLENE GLYCOL
dapagliflozin drug variants not containing POLYETHYLENE GLYCOL
Excipient focus: POLYETHYLENE GLYCOL 3350
dapagliflozin drug variants containing POLYETHYLENE GLYCOL 3350
dapagliflozin drug variants not containing POLYETHYLENE GLYCOL 3350
Excipient focus: POLYETHYLENE GLYCOL 400
dapagliflozin drug variants containing POLYETHYLENE GLYCOL 400
| Company | Ingredient | NDC |
|---|---|---|
| AstraZeneca Pharmaceuticals LP | dapagliflozin and saxagliptin | 0310-6780 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POLYETHYLENE GLYCOL 400
Excipient focus: POLYETHYLENE GLYCOL 4000
dapagliflozin drug variants containing POLYETHYLENE GLYCOL 4000
| Company | Ingredient | NDC |
|---|---|---|
| Ascend Laboratories LLC | dapagliflozin | 67877-608 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POLYETHYLENE GLYCOL 4000
Excipient focus: POLYETHYLENE GLYCOL 6000
dapagliflozin drug variants containing POLYETHYLENE GLYCOL 6000
| Company | Ingredient | NDC |
|---|---|---|
| Zydus Pharmaceuticals USA Inc | dapagliflozin | 70710-1380 |
| Zydus Lifesciences Limited | dapagliflozin | 70771-1714 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POLYETHYLENE GLYCOL 6000
Excipient focus: POLYOXYL 40 HYDROGENATED CASTOR OIL
dapagliflozin drug variants containing POLYOXYL 40 HYDROGENATED CASTOR OIL
| Company | Ingredient | NDC |
|---|---|---|
| Ajanta Pharma USA Inc | dapagliflozin | 27241-151 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POLYOXYL 40 HYDROGENATED CASTOR OIL
Excipient focus: POLYSORBATE 80
dapagliflozin drug variants containing POLYSORBATE 80
| Company | Ingredient | NDC |
|---|---|---|
| Ascend Laboratories LLC | dapagliflozin | 67877-608 |
| Florida Pharmaceutical Products LLC | dapagliflozin | 71921-420 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POLYSORBATE 80
Excipient focus: POLYVINYL ALCOHOL
dapagliflozin drug variants containing POLYVINYL ALCOHOL
dapagliflozin drug variants not containing POLYVINYL ALCOHOL
Excipient focus: POVIDONE
dapagliflozin drug variants containing POVIDONE
| Company | Ingredient | NDC |
|---|---|---|
| Apotex Corp | dapagliflozin | 60505-4911 |
| Lupin Pharmaceuticals Inc | dapagliflozin | 70748-105 |
| Lupin Pharmaceuticals Inc | dapagliflozin and metformin hydrochloride | 70748-101 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POVIDONE
Excipient focus: POVIDONE K90
dapagliflozin drug variants containing POVIDONE K90
| Company | Ingredient | NDC |
|---|---|---|
| Ascend Laboratories LLC | dapagliflozin and metformin hydrochloride | 67877-619 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing POVIDONE K90
Excipient focus: SILICON DIOXIDE
dapagliflozin drug variants containing SILICON DIOXIDE
dapagliflozin drug variants not containing SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Sandoz Inc | dapagliflozin | 0781-5985 |
| Apotex Corp | dapagliflozin | 60505-4911 |
| >Company | >Ingredient | >NDC |
Excipient focus: SODIUM HYDROXIDE
dapagliflozin drug variants containing SODIUM HYDROXIDE
| Company | Ingredient | NDC |
|---|---|---|
| AstraZeneca Pharmaceuticals LP | dapagliflozin saxagliptin and metformin hydrochloride | 0310-6925 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing SODIUM HYDROXIDE
Excipient focus: SODIUM LAURYL SULFATE
dapagliflozin drug variants containing SODIUM LAURYL SULFATE
dapagliflozin drug variants not containing SODIUM LAURYL SULFATE
Excipient focus: SODIUM STEARYL FUMARATE
dapagliflozin drug variants containing SODIUM STEARYL FUMARATE
dapagliflozin drug variants not containing SODIUM STEARYL FUMARATE
Excipient focus: STEARIC ACID
dapagliflozin drug variants containing STEARIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Novadoz Pharmaceuticals LLC | dapagliflozin and saxagliptin | 72205-438 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing STEARIC ACID
Excipient focus: TALC
dapagliflozin drug variants containing TALC
dapagliflozin drug variants not containing TALC
Excipient focus: TITANIUM DIOXIDE
dapagliflozin drug variants containing TITANIUM DIOXIDE
dapagliflozin drug variants not containing TITANIUM DIOXIDE
Excipient focus: TRIETHYL CITRATE
dapagliflozin drug variants containing TRIETHYL CITRATE
| Company | Ingredient | NDC |
|---|---|---|
| Sandoz Inc | dapagliflozin | 0781-5985 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing TRIETHYL CITRATE
Excipient focus: WATER
dapagliflozin drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| AstraZeneca Pharmaceuticals LP | dapagliflozin saxagliptin and metformin hydrochloride | 0310-6925 |
| >Company | >Ingredient | >NDC |
dapagliflozin drug variants not containing WATER
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Site Map
DrugPatentWatch Alternatives
LOE / Generic Entry Opportunies 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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